News | October 20, 2010

Study Results Show Low Infection Rates for CIED Procedures

October 20, 2010 – New study results show that patients undergoing cardiac implantable electronic device (CIED) implantation had a 99.5 percent rate of successful implantation with an overall infection rate of 0.48 percent in the first 1.9 months following the procedure. The COMMAND study looked at the FDA-cleared AIGISRx Antibacterial Envelope, by TYRX.

There were no infections in patients receiving initial implantations of pacemakers, implantable cardioverter-defibrillators, or cardiac resynchronization therapy devices. The infection rate within the highest risk cohort, ICD/CRT-D replacements/revisions, demonstrated 70 percent fewer infections than some previous studies.

The results were published in the October online issue of Pacing and Clinical Electrophysiology, the official journal of the International Cardiac Pacing and Electrophysiology Society.

“The COMMAND Study provides additional evidence that the AIGISRx Antibacterial Envelope offers physicians an effective means for addressing the significant unmet clinical need for additional CIED infection prophylaxis as described in the American Heart Association and Heart Rhythm Society CRM Infection Guidelines published earlier this year,” said Heather Bloom, M.D., director of electrophysiology at the Atlanta VA Medical Center, assistant professor of medicine, Emory University, and lead author on the COMMAND Study report.

Currently, more than 500,000 CIEDs are implanted in the United States each year, and infections occur in association with 1 percent to 7 percent of these devices and are associated with significant morbidity, mortality and expense. The AIGISRx Antibacterial Envelope is designed to reduce infection risk by eluting the antibiotics minocycline and rifampin for 7 to 10 days after implantation with the CIED. This antibiotic combination has been shown to reduce infections associated with medical devices in multiple randomized controlled trials.

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